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1 Indications & Usage Hydroxyprogesterone Caproate Injection Is A Progestin Indicated To Reduce The Risk Of Preterm Birth In Women With A Singleton Pregnancy Who Have A History Of Singleton Spontaneous Preterm Birth. The Effectiveness Of Hydroxyprogesterone Caproate Injection, Usp Is Based On Improvement In The Proportion Of Women Who Delivered < 37 Weeks Of Gestation. There Are No Controlled Trials Demonstrating A Direct Clinical Benefit, Such As Improvement In Neonatal Mortality And Morbidity. Limitation Of Use: While There Are Many Risk Factors For Preterm Birth, Safety And Efficacy Of Hydroxyprogesterone Caproate Injection Has Been Demonstrated Only In Women With A Prior Spontaneous Singleton Preterm Birth. It Is Not Intended For Use In Women With Multiple Gestations Or Other Risk Factors For Preterm Birth. Hydroxyprogesterone Caproate Injection Is A Progestin Indicated To Reduce The Risk Of Preterm Birth In Women With A Singleton Pregnancy Who Have A History Of Singleton Spontaneous Preterm Birth(1). The Effectiveness Of Hydroxyprogesterone Caproate Injection Is Based On Improvement In The Proportion Of Women Who Delivered < 37 Weeks Of Gestation (14). There Are No Controlled Trials Demonstrating A Direct Clinical Benefit, Such As Improvement In Neonatal Mortality And Morbidity. Limitation Of Use : Hydroxyprogesterone Caproate Injection Is Not Intended For Use In Women With Multiple Gestations Or Other Risk Factors For Preterm Birth. (1)
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